The present invention relates to a packaging system, and more particularly to a packaging system and method for packaging a sterilizable item for aseptic presentation onto a sterile field.
Since the days of Joseph Lister medical professionals have recognized the need for maintaining sterile conditions, especially in an operating room. Thus, under standard operating room procedure sterile equipment covers and patient drapes protect and define a sterile surgical field, and all items within the defined surgical field must be sterile.
Such items as equipment covers, patient drapes, and other medical supplies may be used only a single time, and ready-to-use items are frequently purchased from commercial manufacturers. Alternatively, the items, whether reusable or single-use, may be processed within a facility providing health care such as a hospital, surgical center, clinic or office. The item processor must package the item in a manner that will protect and maintain both the sterility of the item and the sterility of the surgical field during the introduction of the item onto the surgical field. In practice this has meant that many items intended for use in a surgical field are double packaged: a completely sealed outer packaging element surrounds an inner packaging element in or on which the sterilizable item is located. At some point in the production cycle the double-packaged item is sterilized so that when the item arrives at the point of use, both the item and the inner packaging element are sterile.
To introduce a double-packaged sterile item onto a sterile field, typically a non-scrubbed attendant opens and discards the outer packaging element surrounding the inner packaging element and the item. The attendant then carefully opens the inner packaging element and presents the sterile item to scrubbed personnel for transfer to the sterile field. The non-scrubbed attendant must exercise great care in order to maintain the sterility and integrity of the item and thus of the sterile field.
The inner packaging element is intended to provide a second level of protection and to maintain the sterility of the item and of the sterile field during introduction of the item onto the sterile field. An example of a typical inner packaging element is a sheet of material folded in a so-called central supply wrap (CSR), a name that originally identified a hospital central supply department as the source of the packaged item. The name now designates a particular type of an envelope fold.
In a central supply wrap, an item is placed on a diagonal in the center of a square sheet of fabric that is proportionally sized to adequately enclose the item. Each corner of the sheet is folded over the item sequentially, and the fourth corner is tucked under the first three proximate the center of the item, with an end of the fourth corner left exposed for later opening of the package. To facilitate opening a CSR package, the end of each corner may be folded back upon itself to provide a tab for the package opener to grasp.
When opening a CSR package, the non-scrubbed attendant holds the package in a holding hand and with the other hand grasps the exposed corner at the tab, pulls the corner of the sheet away from himself or herself around and under the holding hand, and tucks the corner into the holding hand. The attendant pulls each corner of the sheet away from the item and around the holding hand, tucking the corners between the fingers of the holding hand to provide a protective hand cover. Since only the holding hand has a protective cover when the item has been exposed, the non-scrubbed attendant preferably is assisted by a second, scrubbed, person who removes the sterile item from the holding hand and who actually introduces the sterile item onto the sterile field.
When the non-sterile attendant is opening the CSR package, if any edge of the sheet escapes the holding hand or inadvertently touches the sterile item as it is being exposed, the item has been contaminated. Of course, if the attendant is unaware of the contamination and introduces the item onto the sterile field, the entire field has been contaminated. Such a contamination increases the potential for post-operative infection, currently occurring at a rate of about 7% nationally, which increases both the cost and the risk of the medical procedure. Even discarding the contaminated item increases the cost of the procedure, in terms of actual items used and total time expended during the procedure.
Thus, a need exists for a packaging system for a sterilizable item that permits opening of the system without significant risk of contamination or damage to the item and that permits easy aseptic presentation of the item for use.
According to one aspect of the present invention such a need is satisfied by placing a sterilizable item into a sterilizable tubular member so that the item contacts a portion of an inside surface at a closed end of the tubular member. A border portion is formed on the tubular member; a first edge of the border portion is attached to the tubular member proximate an opening in the tubular member for the circumference of the opening and a second opposing edge of the border portion is spaced apart from the first edge by a width of the border portion. A fold line is formed in the border portion and the tubular member above the item. The item is enclosed in the tubular member by placing the first edge of the border portion under the second edge of the border portion between the border portion and the tubular member. After sterilization the item can be dispensed from the sterile tubular member and transferred onto a sterile field by a single non-scrubbed attendant while maintaining the sterility and integrity of the item and the field.
According to another aspect of the invention, a packaging system for a sterilizable item includes a sterilizable flexible elongate tubular member having an outside, a closed end and an open end having a circumference. The item is placeable in the tubular member proximate the closed end. The tubular member includes a border portion having a width, an attached edge and an opposing edge spaced apart from the attached edge by the width. The attached edge is attached to the tubular member proximate the open end along the circumference of the open end and the opposing edge is located proximate the outside of the tubular member. The opposing edge receives thereunder the attached edge of the border portion to enclose the item in the tubular member. The packaging system also includes a sterilizable container for receiving therein the tubular member and the item. The packaging system can be opened and the item dispensed onto the sterile field in a manner that prevents the inadvertent contamination of the sterilized item. In addition, after the item has been dispensed the elongate tubular member can be used as a convenient waste container during and immediately after the surgery.
The foregoing and other objectives, features, and advantages of the invention will be more readily understood upon consideration of the following detailed description of the invention, taken in conjunction with the accompanying drawings.